Expel™ Drainage Catheter

Indications, Safety, and Warnings

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Rx only. Prior to use, please see the complete “Directions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions.

Expel™ Drainage Catheters

The drainage catheter is intended to provide percutaneous drainage of abscess fluid collections.

Expel Nephrostomy Drainage Catheter and Kit

The drainage catheter is intended to provide external drainage of the urinary tract.

CONTRAINDICATIONS

The drainage catheter is contraindicated where percutaneous drainage catheterization is unacceptable.

For Expel Large Capacity, the drainage catheter is contraindicated where large diameter (≥ 16F) percutaneous drainage catheterization is unacceptable.

WARNINGS

Do not use catheter for feeding tube/gastrostomy procedures. Exposure to gastric fluids may damage the catheter.

Not for bilio-pancreatic use.

PRECAUTIONS

These recommendations are meant to serve only as a basic guide to the use of this catheter. Percutaneous drainage should not be undertaken without comprehensive knowledge of the indications, techniques, and risks of the procedure.

Where long-term use is indicated, it is recommended that indwelling time not exceed the following limits, and that the physician evaluate the catheter before this time has elapsed:

90 days, for Expel MPD and MPDL Draining Catheter and Kit;

30 days, for Expel Nephrostomy Drainage Catheter and Kit.

Catheters attached to suction should follow normal clinical practices in selecting a static vacuum level. Testing has demonstrated the catheters can withstand a negative pressure of 200 mmHg (26.7 kPa).

ADVERSE EVENTS

The complications that may result from the use of these devices include, but are not limited to:

Catheter Occlusion and/or Dislodgment

Encrustation

Fistula

Hemorrhage/Hematoma

Infection/Sepsis

Pain

Perforation

Peritonitis

Pneumothorax

Expel™ Stent Systems

INTENDED USE / INDICATIONS FOR USE

The Expel Nephroureteral Stents are intended to establish internal drainage from the ureteropelvic junction to the bladder while maintaining external access to the stent as well as providing external drainage.

The Expel Ureteral Stent System is delivered percutaneously and is intended to establish drainage from the ureteropelvic junction to the bladder and stenting of the ureter for all patients in whom it is desirable to place a drain which does not extend externally.

CONTRAINDICATIONS

The Expel Nephroureteral Stents and Expel Ureteral Stent System are contraindicated where percutaneous drainage catheterization is unacceptable.

WARNINGS

Do not use the stent for feeding tube/gastrostomy procedures. Exposure to gastric fluids may damage the stent.

PRECAUTIONS

These recommendations are meant to serve only as a basic guide to the use of this stent. The performance of urinary collections and percutaneous placement of ureteral stents should not be undertaken without comprehensive knowledge of the indications, techniques, and risks of the procedure.

Where long-term use is indicated it is recommended that the indwelling time of the stent does not exceed 30 days. This stent should be evaluated by the physician on or before the 30 days post-placement.

Testing has demonstrated the Nephroureteral stent can withstand a negative pressure of 200 mmHg (26.7 kPa).

ADVERSE EVENTS

The complications that may result from the use of these devices include, but are not limited to: